Medical device adverse event monitoring management system

Medical device adverse event monitoring management system In order to strengthen the hospital's medical device adverse event monitoring management, according to the national "supervision and management of medical devices regulations", "medical device adverse event monitoring and re-evaluation of the management approach (for trial implementation)" to develop this system. First, establish a sound organizational structure, clear job responsibilities 1, the establishment of medical device adverse event monitoring leading group Leader: Luo Zebin Deputy Leader: Mo Fan Li Rentong Liaison: Li Rentong Members: Lin Haitao Guan Chengnong Lai Minzhen Xu Rui Tan Ling Zhou Yu Wu Zhenzhang Liu Jianjun Yao Huaguo Tan Hongchang Zhang Fenglan Tan Jianxin Li Ruizhuang Chen Yixiong Li Yuping Ao Bing day-to-day work and convene the meeting, the meeting records by the quality assurance department is responsible for. The leading group is fully responsible for the work related to the monitoring and management of medical device adverse events in the whole hospital and performs the following main duties: (1) to be responsible for the planning of the monitoring and management of medical device adverse events in the hospital and the development, modification, supervision and implementation of the relevant systems; (2) to be responsible for the missionary work of the hospital's monitoring and management of medical devices; (3) to study and analyze the dynamics of the monitoring and management of medical devices and existing problems, and regularly organize and hold daily monitoring and management meetings. Problems, regularly organize and convene daily monitoring work summary meeting, discuss and put forward ideas and suggestions for improvement; (4) develop and improve the operating procedures for the use of high-risk medical devices, organize and train the staff to standardize the operation of the use of high-risk medical devices; (5) formulate the emergency response plan for the sudden and mass occurrence of adverse events of medical devices, especially those that lead to death or serious injuries; (6) for the reported adverse events, organize and discuss within one week to discuss with the staff on the management of medical device adverse events, and to make recommendations for improvement. Adverse events, within one week to discuss the organization and develop countermeasures; (7) notify and convey the feedback from the superior medical device adverse event monitoring technical institutions. 2, clear division of functions daily monitoring: Asset Management Department, Procurement Department **** the same responsible for the daily monitoring of medical device adverse events. Regular summary: Asset Management Department before January 5 each year will be the previous year's medical device adverse event monitoring summary report submitted to the Quality Assurance Department. And keep the original information of monitoring for examination. Supervision and management: The Quality Assurance Department supervises the implementation of medical device adverse event monitoring by the Asset Management Department and the Procurement Department through quarterly evaluation of the quality of logistic services.3. Establishment of part-time liaison officers for medical device adverse events in each relevant department (including Cardiology, Nephrology, Surgery, Obstetrics and Gynecology, Ophthalmology, Radiology, Ultrasonography, Nuclear Medicine, Radiotherapy, Laboratory and Blood Transfusion, etc). Set up part-time liaison officers to work under the leadership of the leading group and functional departments. Second, the establishment of medical device use adverse event reporting system 1, clinical use of the department found or suspected occurrence of medical device adverse events, immediately fill out the "Suspected Medical Device Adverse Event Reporting Form" in triplicate, respectively, reported to the Medical Department (or Nursing Department), the Asset Management Department and the Procurement Department. 2, the Medical Department, the Nursing Department after the investigation and verification of the report on the statement forwarded to the Department of Quality Assurance. 3, the Department of Quality Assurance in the Department of the reported After the occurrence of medical device adverse events, the events leading to death within 5 working days from the date of discovery or knowledge, the events leading to serious injury, may lead to serious injury or death within 15 working days to Zhanjiang City, Zhanjiang Medical Device Adverse Event Monitoring Technical Organization; for sudden, mass occurrence of medical device adverse events, immediately to Zhanjiang City, Zhanjiang Medical Device Adverse Event Monitoring Technical Organization, and within 24 hours to report the "Suspected Medical Device Adverse Event Monitoring Technical Organization". Within 24 hours of the "Suspected Medical Device Adverse Event Report Form". 4, Purchasing Department to contact the relevant manufacturers. 5, Quality Assurance Department to save the medical device adverse event monitoring records, for the medical devices that cause adverse events monitoring records are saved to the medical device on the use of the period of time indicated after 2 years, and the record retention period of not less than 5 years. 6, the reporting process, 6, the report process Clinical use of the department (fill in the form) ↓ ↙ ↓ ↓ ↓ </b> Asset Management Department Medical (Nursing) Department Purchasing Department ↓ ↓ ↓ Quality Assurance Department Manufacturer ↓ Hospital Leadership ↓ 兾 Supervision and management of Zhanjiang City, Guangdong Province, China </B> Third, the establishment of the use of medical equipment product traceability system 1, for the implementation of implantable medical devices to track the implementation of tracking and management. 2, the use of implantable medical devices in all clinical departments should be timely registration for the record, the strict implementation of the relevant provisions of the State. The use of implantable medical devices in each clinical department should be registered and filed in a timely manner and the relevant national regulations should be strictly implemented. Implantable medical devices include orthopedic internal fixation implantation devices, artificial joints, artificial crystals, artificial breasts, implantable pacemakers, artificial heart valves, vascular or luminal catheterization stents, and other metal or polymer implantation devices, etc. 3, the clinical use of the department of the traceability of the product registration information mainly covers the name of the production company, the place of production, the specifications of the product model, the expiration date, the batch number, the medical device registration certificate number, product quality assurance certificate, etc. Registration certificate number, product quality guarantee certificate, etc. 4、Quality Assurance Department regularly supervise and check the registration.